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TITLE 64 LEGISLATIVE RULE

BUREAU FOR PUBLIC HEALTH SERIES 110

MEDICAL CANNABIS PROGRAM – GROWER/PROCESSORS

§64-110-1. General.

1.1. Scope. The provisions of this include general provisions related to grower/processors pursuant to

the West Virginia Medical Cannabis Act (W.Va. Code §§ 16A-1-1 et seq.)

1.2. Authority. W. Va. Code §§16A-1-1 et seq.

1.3. Filing Date.

1.4. Effective Date.

1.5. Sunset Provision. This rule shall terminate and have no further force or effect upon the expiration

of five years from its effective date.

1.6. Applicability. This rule series applies to a person or entity that desires to hold a permit as a

medical cannabis organization in the state.

§64-110-2. Definitions. The following words and terms, when used in this rule, have the following

meanings, unless the context clearly indicates otherwise:

2.1. “Act” means the West Virginia Medical Cannabis Act (W.Va. Code §§ 16A-1-1 et seq.)

2.2. “Adverse event” means an injury resulting from the use of medical cannabis dispensed at a

dispensary. An injury includes physical harm, mental harm or loss of function.

2.3. “Adverse loss” means a loss, discrepancy in inventory, diversion or theft of seeds, immature

medical cannabis plants, medical cannabis plants, medical cannabis, funds or other property of a

medical cannabis organization.

2.4. “Applicant” means a person who wishes to submit or submits an application to the bureau for a

permit to operate as a grower/processor or dispensary, or both, under the Act and this rule.

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2.5. “Bureau” means the West Virginia Bureau for Public Health within the West Virginia Department

of Health and Human Resources.

2.6. “CBD” means Cannabidiol.

2.7. “Caregiver” means an individual over 21 years of age, or if the patient is under 18 years of age, an

individual who is designated by a patient under W.Va. Code §16A-5-6(2).

2.8. “Certified medical use” means the acquisition, possession, use or transportation of medical

cannabis by a patient, or the acquisition, possession, delivery, transportation or administration of

medical cannabis by a caregiver, for use as part of the treatment of the patient's serious medical

condition, as authorized in a patient certification issued under the act, including enabling the

patient to tolerate treatment for the serious medical condition.

2.9. “Clinical Registrant” means an entity that:

2.9.a. Holds a permit as both a grower/processor and a dispensary.

2.9.b. Has a contractual relationship with an academic clinical research center under which the

academic clinical research center or its affiliate provides advice to the entity, regarding,

among other areas, patient health and safety, medical applications and dispensing and

management of controlled substances.

2.10. “Controlled substance” means a drug, substance or immediate precursor included in

Schedules I-V as listed in the Uniform Controlled Substance Act (W.Va. Code §§60A-2-1 et seq.).

2.11. “Dispensary” means:

2.11.a. A person who holds a permit issued by the bureau to dispense medical cannabis.

2.11.b. The term does not include a health care medical cannabis organization as defined under

W.Va. Code §§ 16-A-13-1 et seq.

2.12. “Electronic tracking system” means an electronic seed-to-sale system approved by the bureau

what is implemented by:

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2.12.a. A grower/processor to log, verify and monitor the receipt, use and sale of seeds,

immature medical cannabis plants or medical cannabis plants, the funds received by a

grower/processor for the sale of medical cannabis to another medical cannabis organization,

the disposal of medical cannabis waste and the recall of defective medical cannabis.

2.12.b. A dispensary to log, verify and monitor the receipt of medical cannabis product from a

grower/processor, the verification of the validity of an identification card presented by a

patient or caregiver, the dispensing of medical cannabis product to a patient or caregiver,

the disposal of medical cannabis waste and the recall of defective medical cannabis.

2.12.c. An approved laboratory to log, verify and monitor the receipt of samples and test samples

for testing, the results of tests performed by the approved laboratory, and the disposal of

tested and untested samples and test samples.

2.13. ”Employee” means an individual who is hired for a wage, salary, fee or payment to perform work

for an applicant or permittee.

2.14. ”Excipients” means solvents, chemicals or materials reported by a medical cannabis organization

and approved by the bureau for use in the processing of medical cannabis.

2.15. ”Facility” means a structure and other appurtenances or improvements where a medical

cannabis organization grows and processes or dispenses medical cannabis.

2.16. ”Financial backer” means an investor, mortgagee, bondholder, note holder, or other source of

equity, capital or other assets other than a financial institution.

2.17. ”Form of medical cannabis” means the characteristics of the medical cannabis recommended or

limited for a particular patient, including the method of consumption and any particular dosage,

strain, variety and quantity or percentage of medical cannabis or particular active ingredient.

2.18. ”Grower/processor means:

2.18.a. A person who holds a permit from the bureau under the act to grow and process medical

cannabis.

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2.18.b. The term does not include a health care medical cannabis organization as defined under

W.Va. Code §§ 16A-13-1 et seq.

2.19. ”Health care medical cannabis organization” means a vertically integrated health system

approved by the bureau to dispense medical cannabis or grow and process medical cannabis, or

both, in accordance with a research study under W.Va. Code §§ 16A-13-1 et seq.

2.20. ”Hydroponic nutrient solution” means a mixture of water, minerals and essential nutrients

without soil used to grow medical cannabis plants.

2.21. ”Identification card” means a document issued under W.Va Code § 16A-5-1 that authorizes

access to medical cannabis under the Act.

2.22. ”Immature medical cannabis plant” means a rootless, nonflowering part of a medical cannabis

plant that is no longer than 12 inches and no wider than 12 inches produced from a cutting,

clipping or seedling and that is in a growing container that is no larger than two inches wide and

two inches tall that is sealed on the sides and bottom.

2.23. ”Laboratory” means a place, establishment or institution within the state of West Virginia that

has been issued a certificate of accreditation.

2.24. ”Limited access area” means any area on a site or within a facility where:

2.24.a. Immature medical cannabis plants or medical cannabis plants are growing or being

processed into medical cannabis.

2.24.b. Immature medical cannabis plants, medical cannabis plants, medical cannabis or medical

cannabis products are being loaded into or out of transport vehicles.

2.24.c. Medical cannabis is packaged for sale or stored.

2.24.d. Medical cannabis waste is processed, stored or destroyed.

2.24.e. Surveillance system devices are stored.

2.25. ”Medical cannabis” means cannabis for certified medical use as set forth in the Act.

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2.26. ”Medical cannabis container” means a sealed, traceable, food compliant, tamper resistant,

tamper evident container used for the purpose of containment of packaged medical cannabis

being transported from a grower/processor to a medical cannabis organization or a laboratory.

2.27. ”Medical cannabis organization” means:

2.27.a. A dispensary or a grower/processor.

2.27.b. The term does not include a health care medical cannabis organization under sections

W.Va. Code 16A-13-1 et seq. or a clinical registrant under W.Va. Code §§16A-14-1 et seq.

2.28. ”Medical cannabis plant” means a plant which is greater than 12 vertical inches in height from

where the base of the stalk emerges from the growth medium to the tallest point of the plant, or

greater than 12 horizontal inches in width from the end of one branch to the end of another

branch.

2.29. ”Medical cannabis program” means the program authorized under the Act and implemented by

the bureau.

2.30. ”Medical cannabis waste” means:

2.30.a. Solid, liquid, semi-solid or contained gaseous materials that are generated by a

grower/processor or an approved laboratory.

2.30.b. The term includes:

2.30.b.1. Unused, surplus, returned, recalled, contaminated or expired medical cannabis.

2.30.b.2. Any medical cannabis plant material that is not used in the growing, harvesting or

processing of medical cannabis, including flowers, stems, trim, leaves, seeds, dead

medical cannabis plants, dead immature medical cannabis plants, unused medical

cannabis plant parts, unused immature medical cannabis plant parts or roots.

2.30.b.3. Spent hydroponic nutrient solution.

2.30.b.4. Unused containers for growing immature medical cannabis plants or medical

cannabis plants or for use in the growing and processing of medical cannabis.

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2.30.b.5. Unused fertilizers and pesticides.

2.30.b.6. Unused excipients.

2.30.b.7. Wastewater.

2.31. ”Municipality” incorporated city, town or village in the state.

2.32. ”Nutrient” means the essential elements and compounds necessary for the growth, metabolism

and development of medical cannabis plants.

2.33. ”Nutrient practice” means the use by a grower/processor of essential elements and compounds

necessary for the growth, metabolism and development of seeds, immature medical cannabis

plants or medical cannabis plants.

2.34. ”Operations” means the time at which the bureau determines that a medical cannabis

organization is ready, willing and able to properly carry on the activity for which a permit has

been issued under this rule, including the implementation of an electronic tracking system.

2.35. ”Operator” means an individual who directly oversees or manages the day-to-day business

functions for an applicant or permittee and has the ability to direct employee activities onsite and

offsite or within a facility for which a permit is sought or has been issued under this rule.

2.36. ”Patient” means an individual who:

2.36.a. Has a serious medical condition.

2.36.b. Has met the requirements for certification under the Act.

2.36.c. Is a resident of the State of West Virginia.

2.37. ”Permit” means an authorization issued by the bureau to an applicant to conduct activities

authorized under the Act.

2.38. ”Permittee” means a person who has been issued an authorization to operate as a medical

cannabis organization under the Act and this rule.

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2.39. ”Person” means a natural person, corporation, foundation, organization, business trust, estate,

limited liability company, licensed corporation, trust, partnership, limited liability partnership,

association or other form of legal business entity.

2.40. ”Practitioner” means a physician who is registered with the bureau under W.Va. Code §16D-4-1.

2.41. ”Principal” means an officer, director or person who directly or beneficially owns securities of an

applicant or permittee, or a person who has a controlling interest in an applicant or permittee or

who has the ability to elect the majority of the board of directors of an applicant or permittee or

otherwise control an applicant or permittee, other than a financial institution.

2.42. ”Serious medical condition” means any of the following conditions:

2.42.a. Cancer.

2.42.b. Positive status for Human Immunodeficiency Virus or Acquired Immune Deficiency

Syndrome.

2.42.c. Amyotrophic lateral sclerosis.

2.42.d. Parkinson's disease.

2.42.e. Multiple sclerosis.

2.42.f. Damage to the nervous tissue of the spinal cord with objective neurological indication of

intractable spasticity.

2.42.g. Epilepsy.

2.42.h. Neuropathies.

2.42.i. Huntington's disease.

2.42.j. Crohn's disease.

2.42.k. Post-traumatic stress disorder.

2.42.l. Intractable seizures.

2.42.m. Sickle cell anemia.

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2.42.n. Severe chronic or intractable pain of neuropathic origin or severe chronic or intractable

pain in which conventional therapeutic intervention and opiate therapy is contraindicated or

ineffective.

2.42.o. Terminally ill.

2.43. ”Site” means the total area contained within the property line boundaries in which a facility is

operated by a medical cannabis organization.

2.44. ”Solid waste” means the term as defined in W.Va. Code §22.15.2(31) of the Solid Waste

Management Act.

2.45. ”Spent hydroponic nutrient solution” means hydroponic nutrient solution that has been used

and can no longer serve the purpose for which it was produced.

2.46. ”Terminally ill” means a medical prognosis of life expectancy of approximately one year or less if

the illness runs its normal course.

2.47. “THC” means Tetrahydrocannabinol.

2.48. “Transport vehicle” means a vehicle that meets the requirements of the act and is used to

transport medical cannabis between medical cannabis organizations or between medical

cannabis organizations and a laboratory.

2.49. “Unit” means the weight or volume of total usable medical cannabis in the finished product,

calculated in metric units.

§64-110-3. Growers/processors generally.

3.1. The qualifications that a grower/processor shall meet to receive a permit are continuing

qualifications to maintain the permit.

3.2. In addition to any other requirements in the Act or this rule, a grower/processor shall comply with

the following:

3.2.a. A grower/processor may not engage in the business of growing, processing, possessing,

selling or offering to sell medical cannabis to another medical cannabis organization or to a

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clinical registrant within this state without first being issued a permit by the bureau and

without first being determined operational by the bureau as required under W.Va. Code R. §

64-109-16 (Failure to be operational).

3.2.b. A grower/processor may not employ an individual at its facility who is under 18 years of age.

§64-110-4. Plans of operation.

4.1. At the time the bureau determines a grower/processor to be operational, the grower/processor

shall provide the bureau with a full and complete plan of operation for review that includes the

following:

4.1.a. Employment policies and procedures.

4.1.b. Security policies and protocols including:

4.1.b.1. Staff identification measures.

4.1.b.2. Monitoring of attendance of staff and visitors.

4.1.b.3. Alarm systems.

4.1.b.4. Video surveillance.

4.1.b.5. Monitoring and tracking inventory.

4.1.b.6. Personal security.

4.1.c. A process for growing, receiving, processing, packaging, labeling, handling, tracking,

transporting, storing, disposing and recalling of medical cannabis and a process for handling,

tracking, transporting, storing and disposing of medical cannabis waste in accordance with

applicable laws, rules and regulations.

4.1.d. Workplace safety, including conducting necessary safety checks prior to starting the

growing and processing of medical cannabis.

4.1.e. Contamination protocols.

4.1.f. Maintenance, cleaning and sanitation of equipment in the facility or on the site, or both.

4.1.g. Maintenance and sanitation of the site or the facility, or both.

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4.1.h. Proper handling and storage of any solvent, gas or other chemical used in growing or

processing medical cannabis in accordance with this rule and other applicable laws, rules

and regulations.

4.1.i. Quality control, including regulation of the amount of THC in each process lot, proper

labeling and minimization of medical cannabis contamination.

4.1.j. Inventory maintenance and reporting procedures.

4.1.k. The investigation of complaints and potential adverse events from other medical cannabis

organizations, patients, caregivers or practitioners regarding the operation of the

grower/processor.

4.1.l. A recall plan meeting the requirements of section 22 (Complaints about or recall of medical

cannabis).

4.2. A grower/processor shall make the full and complete plan of operation available to the bureau

upon request and during any inspection of the site and facility.

§64-110-5. Grower/processor facilities.

5.1. A grower/processor may only grow, store, harvest or process medical cannabis in an indoor,

enclosed, secure facility as approved by the bureau.

5.2. The following areas of a facility must be clearly marked with proper signage:

5.2.a. Medical cannabis growing and processing areas. These areas shall be easily observed by the

bureau and its authorized agents and by law enforcement.

5.2.b. Nongrowing and non-processing areas.

5.2.c. Limited access areas. All areas of ingress and egress to a limited access area must be clearly

identified by the posting of a sign which must be not less than 12 inches wide and 12 inches

long, composed of letters not less than one-half inch in height, which must state:

Do Not Enter—Limited Access Area—Access Limited to Authorized Personnel and Escorted Visitors.

5.2.d. Areas that include business offices and reception rooms.

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5.3. A facility shall have an enclosed secure area out of public sight for the loading and unloading of

medical cannabis into and from a transport vehicle.

§64-110-6. Start-up inventory.

6.1. A grower/processor may obtain seeds or immature medical cannabis plants from outside of this

state for the purpose of securing its start-up inventory. Seeds or immature medical cannabis

plants obtained from outside of this State shall be obtained within 30 days from the date that the

bureau determines that the grower/processor is operational.

6.2. A grower/processor may not obtain medical cannabis plants from outside of this state at any time.

6.3. A grower/processor shall, within 24 hours of receipt, record in the electronic tracking system each

seed and immature medical cannabis plant that enters the site during the 30-day period under

subsection 6.1.

6.4. After the 30-day period in subsection 6.1, a grower/processor shall only grow medical cannabis

plants from seeds or immature medical cannabis plants located physically in its facility, or

purchase seeds, immature medical cannabis plants or medical cannabis plants from another

grower/processor.

§64-110-7. Visitor access to grower/processor facilities.

7.1. A grower/processor facility may not be open to the general public. A grower/processor shall

require visitors, including vendors, contractors and other individuals requiring access to the

facility for purposes regarding the growing, processing or testing of medical cannabis, to sign a

visitor log and wear a visitor identification badge that is visible to others at all times while on the

site and in the facility.

7.2. A grower/processor shall require visitors to present government-issued identification that

contains a photo to gain access to the site and facility.

7.3. No one under 18 years of age is permitted to enter a grower/processor site and facility.

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7.4. A grower/processor shall post a sign in a conspicuous location at each entrance of the site and

facility that states:

THESE PREMISES ARE UNDER CONSTANT VIDEO SURVEILLANCE. NO ONE UNDER THE AGE OF 18 IS PERMITTED TO ENTER.

7.5. A grower/processor shall do the following when admitting a visitor to its site and facility:

7.5.a. Require the visitor to sign a visitor log upon entering and leaving the facility.

7.5.b. Check the visitor's government-issued identification to verify that the name on the

identification provided matches the name in the visitor log. A photocopy of the identification

must be retained with the log.

7.5.c. Issue a visitor identification badge with the visitor's name and company, if applicable, and a

badge number.

7.5.d. Escort the visitor while the visitor remains in the facility or on the site.

7.5.e. Ensure that the visitor does not touch any medical cannabis plant or medical cannabis

located in a limited access area.

7.6. The following apply to the visitor log required under subsections 7.1 and 7.5:

7.6.a. The grower/processor shall maintain the log for four years and make the log available to the

bureau, state or local law enforcement, and other state or local government officials upon

request if necessary to perform the government officials' functions and duties.

7.6.b. The log must include the full name of each visitor, the visitor identification badge number,

the time of arrival, the time of departure and the purpose of the visit, including the areas of

the site and the facility visited and the name of each employee visited.

7.7. This section does not limit the right of the bureau or its authorized agents, or other federal, state

or local government officials, from entering any area of a grower/processor site and facility if

necessary to perform the governmental officials' functions and duties.

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7.8. A principal, financial backer, operator or an employee of a grower/processor may not receive any

type of consideration or compensation for allowing a visitor to enter a limited access area.

§64-110-8. Security and surveillance.

8.1. A grower/processor shall have security and surveillance systems, utilizing commercial-grade

equipment, to prevent unauthorized entry and to prevent and detect an adverse loss. The

security and surveillance systems must include the following:

8.1.a. A professionally-monitored security alarm system that includes the following:

8.1.a.1. Coverage of all facility entrances and exits; rooms with exterior windows, exterior

walls, roof hatches or skylights; storage rooms, including those that contain medical

cannabis and safes; and the perimeter of the facility.

8.1.a.2. A silent security alarm system signal, known as a duress alarm, generated by the entry

of a designated code into an arming station to signal that the alarm user is being

forced to turn off the system.

8.1.a.3. An audible security alarm system signal, known as a panic alarm, generated by the

manual activation of a device intended to signal a life-threatening or emergency

situation requiring law enforcement response.

8.1.a.4. A silent alarm signal, known as a holdup alarm, generated by the manual activation of

a device intended to signal a robbery in progress.

8.1.a.5. An electrical, electronic, mechanical or other device capable of being programmed to

send a prerecorded voice message requesting dispatch, when activated, over a

telephone line, radio or other communication system to a law enforcement, public

safety or emergency services agency.

8.1.a.6. A failure notification system that provides an audible, text or visual notification of any

failure in the systems. The failure notification system must provide by telephone, e-

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mail or text message an alert to a designated security person within the facility within

5 minutes after the failure.

8.1.a.7. Smoke and fire alarms.

8.1.a.8. Auxiliary power sufficient to maintain operation of specified growing and processing

areas identified in the grower/processor's plan of operation for at least 48 hours

following a power outage.

8.1.a.9. The ability to ensure all access doors are not solely controlled by an electronic access

panel to prevent locks from becoming released during a power outage.

8.1.a.10. Motion detectors.

8.1.b. A professionally-monitored security and surveillance system that is operational 24 hours a

day, seven days a week and records all activity in images capable of clearly revealing facial

detail. The security and surveillance system must include the following:

8.1.b.1. Fixed camera placement that allows for a clear image of all individuals and activities in

and around the following:

8.1.b.1.A. All limited access areas.

8.1.b.1.B. A room or area containing a security and surveillance system storage device or

equipment.

8.1.b.1.C. Entrances to and exits from the facility. Entrances and exits must be recorded

from both indoor and outdoor vantage points.

8.1.b.1.D. Rooms with exterior windows, exterior walls, roof hatches, or skylights and

storage rooms, including those that may contain medical cannabis and safes.

8.1.b.1.E. Twenty feet from the exterior of the perimeter of the facility.

8.1.b.2. Auxiliary power sufficient to maintain operation for at least 48 hours following a

power outage.

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8.1.b.3. Ability to operate under the normal lighting conditions of each area under

surveillance.

8.1.b.4. Ability to immediately produce a clear, color, still photograph in a digital format that

meets the requirements of this subsection.

8.1.c. Ability to clearly and accurately display the date and time. The date and time must be

synchronized and set correctly and may not significantly obscure the picture.

8.1.d. Ability to record all images captured by each surveillance camera for a minimum of four

years in a format that may be easily accessed for investigative purposes. The recordings

must be kept:

8.1.d.1. At the facility:

8.1.d.1.A. In a locked cabinet, closet or other secure place to protect it from tampering or

theft.

8.1.d.1.B. In a limited access area or other room to which access is limited to authorized

individuals.

8.1.d.2. At a secure location other than the location of the facility if approved by the bureau.

8.1.e. A security alarm system separate from the facility's primary security system covering the

limited access area or other room where the recordings under subdivision 8.1.d. are stored.

The separate security alarm system must meet the same requirements as the facility's

primary security alarm system.

8.2. The following apply regarding the inspection, servicing or alteration of, and the upgrade to, the

site's and facility's security and surveillance systems:

8.2.a. The systems shall be inspected and all devices tested once every year by a qualified alarm

system vendor and a qualified surveillance system vendor, as approved by the bureau.

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8.2.b. The grower/processor shall conduct maintenance inspections once every month to ensure

that any repairs, alterations or upgrades to the security and surveillance systems are made

for the proper operation of the systems.

8.2.c. The grower/processor shall retain at the facility, for at least four years, records of all

inspections, servicing, alterations and upgrades performed on the systems and shall make

the records available to the bureau and its authorized agents within two business days

following a request.

8.2.d. In the event of a mechanical malfunction of the security or surveillance system that a

grower/processor anticipates will exceed an eight-hour period, the grower/processor shall

notify the bureau immediately and, with bureau approval, provide alternative security

measures that may include closure of the facility.

8.2.e. The grower/processor shall designate an employee to continuously monitor the security and

surveillance systems at the facility.

8.2.f. The following apply regarding records retention:

8.2.f.1. Within two business days following a request, a grower/processor shall provide up to

four screen captures of an unaltered copy of a video surveillance recording to the

bureau or its authorized agents, law enforcement or other federal, state or local

government officials if necessary to perform the governmental officials' functions and

duties.

8.2.f.2. If a grower/processor has been notified in writing by the bureau or its authorized

agents, law enforcement or other federal, state or local government officials of a

pending criminal or administrative investigation for which a recording may contain

relevant information, the grower/processor shall retain an unaltered copy of the

recording for four years or until the investigation or proceeding is closed or the entity

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conducting the investigation or proceeding notifies the grower/processor that it is not

necessary to retain the recording, whichever is longer.

8.3. The grower/processor shall install commercial-grade, nonresidential doors and door locks on each

external door of the facility. Keys or key codes for all doors shall remain in the possession of

designated authorized individuals.

8.4. During all nonworking hours, all entrances to and exits from the site and facility must be securely

locked.

8.5. The grower/processor shall have an electronic back-up system for all electronic records.

8.6. The grower/processor shall install lighting to ensure proper surveillance inside and outside of the

facility.

8.7. A grower/processor shall limit access to a room containing security and surveillance monitoring

equipment to persons who are essential to maintaining security and surveillance operations;

Federal, State and local law enforcement; security and surveillance system service employees;

the bureau or its authorized agents; and other persons with the prior written approval of the

bureau. The following apply:

8.7.a. A grower/processor shall make available to the bureau or the bureau's authorized agents,

upon request, a current list of authorized employees and service employees or contractors

who have access to any security and surveillance areas.

8.7.b. A grower/processor shall keep security and surveillance rooms locked at all times and may

not use these rooms for any other purpose or function.

§64-110-9. Requirements for growing and processing medical cannabis.

9.1. A grower/processor shall use only pesticides, fungicides or herbicides that are approved by the

Department of Agriculture for use on medical cannabis plants and listed in Appendix A

(Acceptable pesticide active ingredients for use). The bureau will periodically publish a notice in

the State Register updating the list of pesticides, fungicides or herbicides.

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9.2. A grower/processor shall use the pesticides, fungicides or herbicides listed in Appendix A in a

manner that is approved by the Department of Agriculture on the basis of federal law and

regulations.

9.3. A grower/processor shall maintain a log of all actions taken to detect pests or pathogens, and the

measures taken for control.

9.4. A grower/processor shall:

9.4.a. Use appropriate nutrient practices.

9.4.b. Use a fertilizer or hydroponic solution of a type, formulation and at a rate to support

healthy growth of plants.

9.4.c. Maintain records of the type and amounts of fertilizer and any growth additives used.

9.5. A grower/processor shall perform visual inspections of growing plants and harvested plant

material to ensure there is no visible mold, mildew, pests, rot, or grey or black plant material that

is greater than an acceptable level as determined by the bureau.

9.6. A grower/processor may not add any additional active ingredients or materials to medical

cannabis that alters the color, appearance, smell, taste, effect or weight of the medical cannabis

unless the grower/processor has first obtained the prior written approval of the bureau.

Excipients must be pharmaceutical grade, unless otherwise approved by the bureau.

9.7. A grower/processor shall have a separate and secure area for temporary storage of medical

cannabis that is awaiting disposal by the grower/processor.

9.8. A grower/processor shall only process the parts of the medical cannabis plant that:

9.8.a. Are free of seeds and stems.

9.8.b. Are free of dirt, sand, debris or other foreign matter.

9.8.c. Contain a level of mold, rot or other fungus or bacterial diseases acceptable to the bureau.

9.9. A grower/processor shall process the medical cannabis plants in a safe and sanitary manner. The

following apply:

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9.9.a. Medical cannabis, raw material and other product used in the processing of medical

cannabis shall be handled on food-grade stainless steel benches or tables.

9.9.b. Proper sanitation shall be maintained.

9.9.c. Proper rodent, bird and pest exclusion practices shall be employed.

9.10. A grower/processor shall install a system to monitor, record and regulate:

9.10.a. Temperature.

9.10.b. Humidity.

9.10.c. Ventilation.

9.10.d. Lighting.

9.10.e. Water supply.

§64-110-10. Forms of medical cannabis.

10.1. A grower/processor may only process medical cannabis for dispensing to a patient or caregiver

in the following forms:

10.1.a. Pill.

10.1.b. Oil.

10.1.c. Topical forms, including gel, creams and ointments.

10.1.d. A form medically appropriate for administration by vaporization or nebulization.

10.1.e. Tincture.

10.1.f. Liquid.

10.2. A grower/processor may not process medical cannabis to dispense in dry leaf or plant form.

10.3. A grower/processor may not manufacture, produce, or assemble any medical cannabis product,

instrument, or device without prior written approval of the bureau.

§64-110-11. Limit on medical cannabis processing.

11.1. In the form intended to be sold to another medical cannabis organization, medical cannabis

must have a specific concentration of total THC and total CBD and must have a consistent

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cannabinoid profile. The concentration of the following cannabinoids, at a minimum, shall be

reported to the bureau by an approved laboratory and include the following on the label:

11.1.a. Tetrahydrocannabinol (THC).

11.1.b. Tetrahydrocannabinol acid (THCA).

11.1.c. Tetrahydrocannabivarin (THCV).

11.1.d. Cannabidiol (CBD).

11.1.e. Cannabinadiolic acid (CBDA).

11.1.f. Cannabidivarine (CBDV).

11.1.g. Cannabinol (CBN).

11.1.h. Cannabigerol (CBG).

11.1.i. Cannabichromene (CBC).

11.1.j. Any other cannabinoid component at > 0.1%.

11.2. Within the first six months after the bureau determines the grower/processor to be operational,

the grower/processor shall provide the bureau with a forecast of the amount of medical cannabis

it projects it will produce and in what form. The grower/processor shall notify the bureau in

writing immediately upon becoming aware of a potential increase or decrease in the forecasted

amount occurring within any subsequent six-month period.

§64-110-12. Inventory data.

12.1. A grower/processor shall maintain the following inventory data in its electronic tracking system

which must include an accounting of and an identifying tracking number for:

12.1.a. The number, weight and type of seeds.

12.1.b. The number of immature medical cannabis plants.

12.1.c. The number of medical cannabis plants.

12.1.d. The number of medical cannabis products ready for sale.

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12.1.e. The number of damaged, defective, expired or contaminated seeds, immature medical

cannabis plants, medical cannabis plants and medical cannabis products awaiting disposal.

12.2. A grower/processor shall establish inventory controls and procedures to conduct inventory

reviews and comprehensive inventories at its facility. The following apply:

12.2.a. Inventory reviews of medical cannabis plants in the process of growing and medical

cannabis and medical cannabis products that are being stored for future sale shall be

conducted monthly.

12.2.b. Comprehensive inventories of seeds, immature medical cannabis plants, medical cannabis

plants, medical cannabis and medical cannabis products shall be conducted at least annually.

12.3. A written or electronic record shall be created and maintained of each inventory conducted

under subsection 12.2 that includes the date of the inventory, a summary of the inventory

findings, and the employee identification numbers and titles or positions of the individuals who

conducted the inventory.

§64-110-13. Equipment, operation and maintenance.

13.1. A grower/processor facility shall have a written process in place to maintain the sanitation and

operation of equipment that comes into contact with medical cannabis to prevent

contamination. The grower/processor shall provide a copy of the written process to the bureau

upon request.

13.2. As part of the written process required under subsection 13.1, a grower/processor shall:

13.2.a. Routinely calibrate, check and inspect the following to ensure accuracy:

13.2.a.1. Automatic, mechanical or electronic equipment.

13.2.a.2. Scales, balances or other measurement devices used in the grower/processor’s

operations.

13.2.b. Maintain an accurate log recording the following:

13.2.b.1. Maintenance of equipment.

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13.2.b.2. Cleaning of equipment.

13.2.b.3. Calibration of equipment.

§64-110-14. Storage requirements.

14.1. A grower/processor shall have separate locked limited access areas for storage of seeds,

immature medical cannabis plants, medical cannabis plants and medical cannabis that are

expired, damaged, deteriorated, mislabeled, contaminated, recalled or whose containers or

packaging have been opened or breached until the seeds, immature medical cannabis plants,

medical cannabis plants and medical cannabis are destroyed or otherwise disposed of as required

under section 23 (Management and disposal of medical cannabis waste).

14.2. A grower/processor shall maintain all storage areas in a clean and orderly condition and free

from infestation by insects, rodents, birds and pests.

§64-110-15. Sanitation and safety in a facility.

15.1. A grower/processor shall maintain its facility in a sanitary condition to limit the potential for

contamination or adulteration of the medical cannabis grown and processed in the facility. The

following apply:

15.1.a. Equipment and surfaces, including floors, counters, walls and ceilings, shall be cleaned and

sanitized as frequently as necessary to protect against contamination, using a sanitizing

agent registered by the United States Environmental Protection Agency, in accordance with

the instructions printed on the label. Equipment and utensils shall be so designed and of

such material and workmanship as to be capable of being adequately cleaned.

15.1.b. Trash shall be properly removed.

15.1.c. Floors, walls and ceilings shall be kept in good repair.

15.1.d. Equipment, counters and surfaces for processing must be food grade quality and may not

react adversely with any solvent being used.

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15.1.e. Adequate protection against pests shall be provided through the use of integrated pest

management practices and techniques that identify and manage plant pathogens and pest

problems, and the regular disposal of trash to prevent infestation.

15.1.f. Toxic cleaning compounds, sanitizing agents, solvents used in the growing and processing

of medical cannabis, and pesticide chemicals must be labeled and stored in a manner that

prevents contamination of seeds, immature medical cannabis plants, medical cannabis

plants and medical cannabis, and in a manner that otherwise complies with other applicable

laws and regulations.

15.2. An employee shall conform to sanitary practices while on duty, including the following:

15.2.a. Maintaining adequate personal hygiene.

15.2.b. Wearing proper clothing, including gloves.

15.2.c. Washing hands thoroughly in an adequate hand-washing area before starting work and at

any other time when hands may have become soiled or contaminated.

15.3. A grower/processor shall provide its employees and visitors with adequate and convenient hand-

washing facilities furnished with running water at a temperature suitable for sanitizing hands. The

following apply:

15.3.a. Hand-washing facilities must be located in processing areas and where good sanitary

practices require employees to wash and sanitize their hands.

15.3.b. Effective nontoxic sanitizing cleansers and sanitary towel service or suitable drying devices

shall be provided.

15.4. A grower/processor shall provide its employees and visitors with adequate, readily accessible

lavatories that are maintained in a sanitary condition and in good repair.

15.5. A grower/processor shall ensure that its facility is provided with a water supply sufficient for its

operations, which shall be derived from a source that is a public water system, or a nonpublic

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system that is capable of providing a safe, potable and adequate supply of water to meet the

operational needs of the facility.

15.6. A grower/processor shall comply with all other applicable state and local building code

requirements.

§64-110-16. Packaging and labeling of medical cannabis.

16.1. A grower/processor shall package and label at its facility each form of medical cannabis prepared

for sale. The original seal of a package may not be broken, except for quality control testing at an

approved laboratory, for adverse loss investigations conducted by the bureau or by a dispensary

that purchased the medical cannabis.

16.2. A grower/processor shall package the medical cannabis in a package that minimizes exposure to

oxygen and that is:

16.2.a. Child-resistant.

16.2.b. Tamper-proof or tamper-evident.

16.2.c. Light-resistant and opaque.

16.2.d. Resealable.

16.3. A grower/processor shall identify each process lot of medical cannabis with a unique identifier.

16.4. A grower/processor shall obtain the prior written approval of the bureau of the content of any

label to be affixed to a medical cannabis package. Each label must:

16.4.a. Be easily readable.

16.4.b. Made of weather-resistant and tamper-resistant materials.

16.4.c. Be conspicuously placed on the package.

16.4.d. Include the name, address and permit number of the grower/processor.

16.4.e. List the form, quantity and weight of medical cannabis included in the package.

16.4.f. List the amount of individual doses contained within the package and the species and

percentage of THC and CBD.

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16.4.g. Contain an identifier that is unique to a particular harvest batch of medical cannabis,

including the number assigned to each harvest lot or process lot in the harvest batch.

16.4.h. Include the date the medical cannabis was packaged.

16.4.i. State the employee identification number of the employee preparing the package and

packaging the medical cannabis.

16.4.j. State the employee identification number of the employee shipping the package, if

different than the employee described in subdivision 16.4.i.

16.4.k. Contain the name and address of the dispensary to which the package is to be sold.

16.4.l. List the date of expiration of the medical cannabis.

16.4.m. Include instructions for proper storage of the medical cannabis in the package.

16.4.n. Contain the following warning stating:

This product is for medicinal use only. Women should not consume during pregnancy or while breastfeeding except on the advice of the practitioner who issued the certification and, in the case of breastfeeding, the infant's pediatrician. This product might impair the ability to drive or operate heavy machinery. Keep out of reach of children.

16.4.o. Contain a warning that the medical cannabis must be kept in the original container in

which it was dispensed.

16.4.p. Contain a warning that unauthorized use is unlawful and will subject the purchaser to

criminal penalties.

16.5. Labeling by a grower/processor of any medical cannabis may not bear:

16.5.a. Any resemblance to the trademarked, characteristic or product-specialized packaging of

any commercially available food or beverage product.

16.5.b. Any statement, artwork or design that could reasonably lead an individual to believe that

the package contains anything other than medical cannabis.

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16.5.c. Any seal, flag, crest, coat of arms or other insignia that could reasonably mislead an

individual to believe that the product has been endorsed, manufactured or approved for use

by any state, county or municipality or any agency thereof.

16.5.d. Any cartoon, color scheme, image, graphic or feature that might make the package

attractive to children.

§64-110-17. Transportation of medical cannabis.

17.1. A grower/processor may transport and deliver medical cannabis to a medical cannabis

organization or an approved laboratory in this State in accordance with this section. The following

apply:

17.1.a. A grower/processor may deliver medical cannabis to a medical cannabis organization or an

approved laboratory only between 7:00 a.m. and 9:00 p.m.

17.1.b. A grower/processor may contract with a third-party contractor for delivery so long as the

contractor complies with this section.

17.1.c. A grower/processor may not transport medical cannabis to any location outside of this

State.

17.1.d. A grower/processor shall use a global positioning system to ensure safe, efficient delivery

of the medical cannabis to a medical cannabis organization or an approved laboratory.

17.2. Vehicles permitted to transport medical cannabis must:

17.2.a. Be equipped with a secure lockbox or locking cargo area.

17.2.b. Have no markings that would either identify or indicate that the vehicle is being used to

transport medical cannabis.

17.2.c. Be capable of being temperature-controlled for perishable medical cannabis, as

appropriate.

17.2.d. Display current State inspection stickers and maintain a current State vehicle registration.

17.2.e. Be insured in an amount that is commercially reasonable and appropriate.

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17.3. A transport vehicle must be staffed with a delivery team consisting of at least two individuals and

comply with the following:

17.3.a. At least one delivery team member shall remain with the vehicle at all times that the

vehicle contains medical cannabis.

17.3.b. Each delivery team member shall have access to a secure form of communication with the

grower/processor, such as a cellular telephone, at all times that the vehicle contains medical

cannabis.

17.3.c. Each delivery team member shall carry an identification badge or card at all times and

shall, upon demand, produce it to the bureau or its authorized agents, law enforcement, or

other Federal, State or local government officials if necessary to perform the government

officials' functions and duties.

17.3.d. Each delivery team member shall have a valid driver's license.

17.3.e. While on duty, a delivery team member may not wear any clothing or symbols that may

indicate ownership or possession of medical cannabis.

17.4. Medical cannabis stored inside the transport vehicle may not be visible from the outside of the

transport vehicle.

17.5. Except as provided in subsection 17.8, a delivery team shall proceed in a transport vehicle from

the facility, where the medical cannabis is loaded, directly to the medical cannabis organization

or approved laboratory, where the medical cannabis is unloaded, without unnecessary delays.

Notwithstanding the foregoing, a transport vehicle may make stops at multiple facilities or

approved laboratories, as appropriate, to deliver medical cannabis.

17.6. A grower/processor shall immediately report to the bureau, either through a designated phone

line established by the bureau or by electronic communication with the bureau in a manner

prescribed by the bureau, vehicle accidents, diversions, losses or other reportable events that

occur during transport of medical cannabis.

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17.7. A grower/processor shall notify the bureau daily of its delivery schedule, including routes and

delivery times, either through a designated phone line established by the bureau or by electronic

communication with the bureau in a manner prescribed by the bureau.

17.8. A transport vehicle is subject to inspection by the bureau or its authorized agents, law

enforcement, or other Federal, State or local government officials if necessary to perform the

government officials' functions and duties. A transport vehicle may be stopped and inspected

along its delivery route or at any medical cannabis organization or approved laboratory.

§64-110-18. Transport manifest.

18.1. A grower/processor shall generate a printed or electronic transport manifest that accompanies

every transport vehicle and contains the following information:

18.1.a. The name, address and permit number of the grower/processor and the name of and

contact information for a representative of the grower/processor who has direct knowledge

of the transport.

18.1.b. The name, address and permit number of the medical cannabis organization or approved

laboratory receiving the delivery and the name of and contact information for a

representative of the medical cannabis organization or approved laboratory.

18.1.c. The quantity, by weight or unit, of each medical cannabis harvest batch, harvest lot or

process lot contained in the transport, along with the identification number for each batch

or lot.

18.1.d. The date and approximate time of departure.

18.1.e. The date and approximate time of arrival.

18.1.f. The transport vehicle's make and model and license plate number.

18.1.g. The identification number of each member of the delivery team accompanying the

transport.

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18.2. When a delivery team delivers medical cannabis to multiple medical cannabis organizations or

approved laboratories, the transport manifest must correctly reflect the specific medical cannabis

in transit. Each recipient shall provide the grower/processor with a printed receipt for the

medical cannabis received.

18.3. All medical cannabis being transported shall be packaged in shipping containers and labeled in

accordance with section 16 (Packaging and labeling of medical cannabis).

18.4. A grower/processor shall provide a copy of the transport manifest to the recipient receiving the

medical cannabis described in the transport manifest. To maintain confidentiality, a

grower/processor may prepare separate manifests for each recipient.

18.5. A grower/processor shall, if requested, provide a copy of the printed transport manifest, and any

printed receipts for medical cannabis being transported, to the bureau or its authorized agents,

law enforcement, or other federal, state or local government officials if necessary to perform the

government officials' functions and duties.

§64-110-19. Transportation of seeds, immature medical cannabis plants and medical cannabis plants.

19.1. A grower/processor may transport seeds, immature medical cannabis plants and medical

cannabis plants within this state for the growing and processing of medical cannabis.

19.2. A grower/processor may not transport seeds, immature medical cannabis plants or medical

cannabis plants to a location outside of this state.

19.3. A grower/processor's authorization to transport seeds, immature medical cannabis plants or

medical cannabis plants shall be subject to the requirements of sections 17, 18 and 20

(Transportation of medical cannabis; transport manifest; and evidence of adverse loss during

transport).

§64-110-20. Evidence of adverse loss during transport.

20.1. If a grower/processor receiving a delivery of medical cannabis or medical cannabis products from

a medical cannabis organization discovers a discrepancy in the transport manifest upon delivery,

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the grower/processor shall refuse acceptance of the delivery and immediately report the

discrepancy to the bureau either through a designated phone line established by the bureau or

by electronic communication with the bureau in a manner prescribed by the bureau, and to the

appropriate law enforcement authorities.

20.2. If a grower/processor discovers evidence of, or reasonably suspects, a theft or diversion of

medical cannabis or medical cannabis products during transport, the grower/processor shall

immediately report its findings or suspicions to the bureau either through a designated phone

line established by the bureau or by electronic communication with the bureau in a manner

prescribed by the bureau and to law enforcement.

20.3. If a grower/processor discovers a discrepancy in the transport manifest, the grower/processor

shall:

20.3.a. Conduct an investigation.

20.3.b. Amend the grower/processor's standard plan of operation, if necessary, to prevent future

discrepancies between the quantity or description of inventory listed in the transport

manifest and the quantity or description of inventory delivered.

20.3.c. Submit a report of the investigation to the bureau. The following apply:

20.3.c.1. A written preliminary report of the investigation shall be submitted to the bureau

within seven days of discovering the discrepancy.

20.3.c.2. A final written report of the investigation shall be submitted to the bureau within 30

days of discovering the discrepancy.

§64-110-21. Electronic tracking system.

A grower/processor shall use the electronic tracking system prescribed by the bureau containing the

requirements in W.Va. Code § 16A-7-1. The bureau will publish notice of the electronic tracking

system to be utilized by a grower/processor in the State Register 60 days prior to the implementation

date of the system.

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§64-110-22. Management and disposal of medical cannabis waste.

22.1. Medical cannabis waste generated by a grower/processor or an approved laboratory shall be

stored, collected and transported in accordance with W.Va. Code §§ 22-15-1 et seq. (Solid Waste

Management Act), provided the medical cannabis waste is not hazardous.

22.2. The following types of medical cannabis waste shall be rendered unusable and unrecognizable

prior to being transported from a grower/processor or an approved laboratory:

22.2.a. Unused, surplus, returned, recalled, contaminated or expired medical cannabis.

22.2.b. Any medical cannabis plant material that is not used in the growing, harvesting or

processing of medical cannabis, including flowers, stems, trim, leaves, seeds, dead medical

cannabis plants, dead immature medical cannabis plants, unused medical cannabis plant

parts, unused immature medical cannabis plant parts or roots.

22.3. Medical cannabis waste is unusable and unrecognizable if all components of the waste are

indistinguishable and incapable of being ingested, inhaled, injected, swallowed or otherwise used

for certified medical use. Acceptable methods of rendering the waste unusable and

unrecognizable include thermal treatment or melting; shredding, grinding or tearing; and

incorporating the medical cannabis waste with other municipal waste.

22.4. Unusable and unrecognizable medical cannabis waste identified in subsection 22.2 and other

solid or semi-solid medical cannabis waste that is not hazardous shall be disposed of at a

permitted municipal waste landfill or processed at a permitted resource recovery facility or

incinerator.

22.5. Wastewater or spent hydroponic nutrient solution generated or produced from the growing,

harvesting or processing of immature medical cannabis plants or medical cannabis plants shall be

managed in accordance with one of the following:

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22.5.a. Discharged into a permitted sewage treatment system in accordance with local, Federal

and State requirements, including The Water Pollution Control Act (W.Va. Code §§ 22-11-1

et seq.).

22.5.b. Treated and discharged into waters of the State under a National Pollutant Discharge

Elimination System permit or water quality management permit in accordance with the

requirements of including The Water Pollution Control Act (W.Va. Code §§ 22-11-1 et seq.).

22.5.c. Disposed in a solid waste landfill if placed in a container that is less than 1 gallon in size.

22.6. Hazardous waste shall be managed in accordance with Federal and State law, rules and

regulations related to hazardous waste, including sections 3001—3024 of the Resource

Conservation and Recovery Act of 1976 (42 U.S.C.A. §§ 6921—6939g), the Hazardous Waste

Management Act (W.Va. Code §§ 22-18-1 et seq.) and rules promulgated thereunder.

22.7. The type of medical cannabis waste identified in subsection 21.2.b. may be composted and

beneficially used at the grower/processor facility through a permit provided the requirements of

W.Va. Code R. §§ 33-3-1 et seq. (Yard Waste Composting Rule) are satisfied, and the compost is

beneficially used at the grower/processor facility as a soil substitute, soil conditioner, soil

amendment, fertilizer or mulch.

§64-110-23. Complaints about or recall of medical cannabis.

23.1. A dispensary shall notify the bureau and the grower/processor immediately upon becoming

aware of any complaint made to the dispensary by a patient, caregiver or practitioner who

reports an adverse event from using medical cannabis purchased by the dispensary from the

grower/processor. A grower/processor shall investigate the report. The following apply:

23.1.a. A grower/processor shall investigate a complaint to determine if a voluntary or mandatory

recall of medical cannabis is necessary or if any further action is required.

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23.1.b. If a grower/processor determines that further action is not required, the grower/processor

shall notify the bureau of its decision and, within 24 hours, submit a written report to the

bureau stating its rationale for not taking further action.

23.2. The following apply to voluntary recalls:

23.2.a. A grower/processor may voluntarily recall medical cannabis from the market at its

discretion for reasons that do not pose a risk to public health and safety.

23.2.b. If a grower/processor initiates a recall for a reason that does not pose a risk to public

health and safety, the grower/processor shall notify the bureau at the time the

grower/processor begins the recall.

23.3. The following apply to mandatory recalls:

23.3.a. If a grower/processor discovers that a condition relating to the medical cannabis grown or

processed at its facility poses a risk to public health and safety, the grower/processor shall:

23.3.a.1. Immediately notify the bureau by phone.

23.3.a.2. Secure, isolate and prevent the distribution of the medical cannabis that may have

been affected by the condition and remains in its possession. The grower/processor

may not dispose of affected medical cannabis prior to notifying the bureau and

coordinating the disposal with the bureau.

23.3.b. If a grower/processor fails to cooperate with the bureau in a recall, or fails to immediately

notify the bureau of a need for a recall under paragraph (1), the bureau may seek a cease

and desist order under W.Va. Code R. § 64-109-21 (General penalties and sanctions) and

the grower/processor may be subject to any other penalties or sanctions provided for in the

Act or this rule.

23.4. A grower/processor's recall plan must include the following:

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23.4.a. Designation of one or more employees to serve as the recall coordinators. A recall

coordinator shall be responsible for, among other duties, accepting the recalled medical

cannabis.

23.4.b. Procedures for identifying and isolating the affected medical cannabis to prevent or

minimize its distribution to patients, caregivers and other medical cannabis organizations

and approved laboratories.

23.4.c. Procedures to retrieve and dispose of the affected medical cannabis.

23.4.d. A communications plan to notify those affected by the recall, including:

23.4.d.1. The manner in which the grower/processor will notify other medical cannabis

organizations or approved laboratories in possession of medical cannabis subject to

the recall.

23.4.d.2. The use of press releases and other appropriate notifications to ensure that patients

and caregivers are notified of the recall if the affected medical cannabis was dispensed

to patients and caregivers.

23.4.e. Procedures for notifying the bureau.

23.4.f. Procedures for entering information relating to the recall into the grower/processor's

electronic tracking system.

23.5. A grower/processor shall follow the procedures outlined in its recall plan, unless the

grower/processor obtains the prior written approval of the bureau. The grower/processor shall

conduct recall procedures in a manner that maximizes the recall of affected medical cannabis and

minimizes risks to public health and safety.

23.6. A grower/processor shall coordinate the disposal of recalled medical cannabis with the bureau.

The bureau or its authorized agents may oversee the disposal to ensure that the recalled medical

cannabis is disposed of in a manner that will not pose a risk to public health and safety.

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23.7. The grower/processor shall enter information relevant to the recall into the electronic tracking

system as part of the daily inventory, including:

23.7.a. The total amount of recalled medical cannabis, including types, forms, harvest batches,

harvest lots and process lots, if applicable.

23.7.b. The amount of recalled medical cannabis received by the grower/processor, including

types, forms, harvest batches, harvest lots and process lots, if applicable, by date and time.

23.7.c. The total amount of recalled medical cannabis returned to the grower/processor, including

types, forms, harvest batches, harvest lots and process lots, if applicable.

23.7.d. The names of the recall coordinators.

23.7.e. From whom the recalled medical cannabis was received.

23.7.f. The means of transport of the recalled medical cannabis.

23.7.g. The reason for the recall.

23.7.h. The number of recalled samples or test samples, types, forms, harvest batches, harvest

lots and process lots, if applicable, sent to approved laboratories, the names and addresses

of the approved laboratories, the dates of testing and the results by sample or test sample.

23.7.i. The manner of disposal of the recalled medical cannabis, including:

23.7.i.1. The name of the individual overseeing the disposal of the recalled medical cannabis.

23.7.i.2. The name of the disposal company, if applicable.

23.7.i.3. The method of disposal.

23.7.i.4. The date of disposal.

23.7.i.5. The amount disposed of by types, forms, harvest batches, harvest lots and process

lots, if applicable.

23.7.j. Any other information required by the bureau.

§64-110-24. Pesticides.

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24.1. The use of a pesticide by a grower/processor in the growing or processing of medical cannabis

shall be in accordance with the West Virginia Pesticide Control Act (W.Va. Code §§ 19-16A-1 et

seq.) and this rule.

24.2. The bureau and the West Virginia Department of Agriculture will cooperate to inspect for and

enforce the requirements of this section.

24.3. The following apply regarding recordkeeping requirements for pesticide applications:

24.3.a. The grower/processor shall maintain a record of each application of a pesticide. The record

must include the following information:

24.3.a.1. The date of application. For a pesticide requiring a re-entry time, the date of

application must include the hour completed.

24.3.a.2. The place of application, including the specific block, section, or immature medical

cannabis plants or medical cannabis plants treated.

24.3.a.3. The size of the area treated.

24.3.a.4. The product name of every pesticide used.

24.3.a.5. The United States Environmental Protection Agency product registration number.

This requirement is unnecessary for products exempted under section 25 of the

Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C.A. § 136w).

24.3.a.6. The total amount of every pesticide used in pounds, ounces, gallons or liters applied

to a treated area.

24.3.a.7. The dosage or rate of application of every pesticide used.

24.3.a.8. If applicable, the employee identification numbers of the individuals involved in

making the pesticide and the permit or certification numbers of the individuals making

or supervising the application.

24.3.a.9. Copies of pesticide labels and Safety Data Sheets for the pesticides used at the

facility.

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24.3.b. A record required to be kept under this section shall be completed within 24 hours of the

completion of the application and maintained for at least 4 years. A record shall be made

immediately available to the bureau or its authorized agents and medical personnel or first

responders in an emergency. A record shall be made available to the bureau of Agriculture

upon request.

24.4. For purposes of enforcement, the West Virginia Pesticide Control Act and W.Va. Code R. 61-12A-

1 et seq., W.Va. Code R. 61-12G-1 et seq., and W.Va. Code R. 61-12H-1 et seq. are incorporated

by reference and adopted as standards for use by the bureau in enforcing this section.

24.5. A grower/processor shall only use the pesticide active ingredients in Appendix A in the growing

and processing of medical cannabis.

24.6. The following words and terms, when used in this section, have the following meanings, unless

the context clearly indicates otherwise:

24.6.a. “Defoliant” means a substance or mixture of substances intended for causing the leaves or

foliage to drop from a plant, with or without causing abscission.

24.6.b. “Desiccant” means a substance or mixture of substances intended for artificially

accelerating the drying of plant tissue.

24.6.c. “Pesticide” means a substance or mixture of substances intended for preventing,

destroying, repelling or mitigating a pest, and a substance or mixture of substances intended

for use as a plant regulator, defoliant or desiccant.

24.6.d. “Plant regulator” means:

24.6.d.1. A substance or mixture of substances intended, through physiological action, for

accelerating or retarding the rate of growth or rate of maturation, or for otherwise

altering the behavior of plants or the produce thereof, but may not include substances

to the extent that they are intended as plant nutrients, trace elements, nutritional

chemicals, plant inoculants and soil amendments.

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24.6.d.2. The term does not include any of the nutrient mixtures or soil amendments

commonly known as vitamin-hormone horticultural products, which are intended for

improvement, maintenance, survival, health and propagation of plants, and are not for

pest destruction and are nontoxic, nonpoisonous in the undiluted packaged

concentration.

§64-110-25. Treatment and quarantine orders.

25.1. If a grower/processor fails or refuses to eradicate a plant pest that is found at its facility, the

bureau, in cooperation with the West Virginia Department of Agriculture, may issue and enforce

a treatment order against the grower/processor, including an order to eradicate, for any

immature medical cannabis plants or medical cannabis plants that may carry or harbor the plant

pest. The order will be issued in writing and set forth the necessary treatment, control or

eradication measures required. If the grower/processor fails or refuses to comply with the order,

the bureau, acting in cooperation with the West Virginia Department of Agriculture, may carry

out the control measures established in the treatment order with all expenses associated with

the measures accruing to the grower/processor.

25.2. The West Virginia Department of Agriculture, acting with the cooperation of the bureau, may

establish a quarantine to prevent the dissemination of plant pests within this state or to prevent

or delay the introduction of a plant pest into this state from any country, state or territory. The

following apply:

25.2.a. Upon finding a plant pest in a facility that has the potential to cause serious damage to

other grower/processors or to agriculture in general, the geographic area in which the plant

pest was found and any adjacent areas as the West Virginia Department of Agriculture

deems necessary may be quarantined.

25.2.b. The quarantine order will establish conditions and restrictions determined by the West

Virginia Department of Agriculture to be necessary to prevent or reduce the movement of

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the plant pest from the quarantined area. Vehicles or any means of conveyance suspected

of carrying the plant pest may also be subject to quarantine and a treatment order under

subsection 25.1 may be issued as necessary to eradicate the plant pest.

25.2.c. The quarantine order may regulate the planting, growing or harvesting of any immature

medical cannabis plants or medical cannabis plants that serve as a host or reservoir for the

plant pest within the quarantined area and may include prohibiting the processing of a

specific harvest batch or harvest lot of medical cannabis within a specific geographic area or

during a specified time period. An immature medical cannabis plant or medical cannabis

plant suspected of harboring the plant pest may be ordered to be treated or destroyed.

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Appendix A. Acceptable Pesticide Active Ingredients for Use

The following pesticides can be used legally in the growing and processing of medical cannabis and in

accordance with the West Virginia Pesticide Control Act (W.Va. Code §§ 19-16A-1 et seq.). Products

containing the following active ingredients must also be labeled for use in greenhouses on food crops to

qualify.

EPA Status Pesticide Type Comments Active Ingredient

25(b) Insecticide Castor Oil

25(b) Insecticide Castor Oil

25(b) Insecticide Cinnamon

25(b) Fungicide, Insecticide Cinnamon Oil

25(b) Fungicide, Insecticide Citric Acid

25(b) Bactericide, Fungicide Clove

25(b) Insecticide Clove Oil

25(b) Fungicide Corn Oil

25(b) Insecticide Cottonseed Oil

25(b) Insecticide Garlic

25(b) Insect Repellant Garlic Oil

25(b) Fungicide Geranoil

25(b) Insecticide Geranium Oil

25(b) Fungicide, Insecticide Lemon Grass Oil

25(b) Insecticide Peppermint Oil

25(b) Insecticide Peroxyaceitic Acid

25(b) Fungicide Potassium Sorbate

25(b) Insecticide Rosemary

25(b) Insecticide Rosemary Oil

25(b) Fungicide, Insecticide, Miticide Sesame Oil

25(b) Fungicide, Insecticide Sodium Lauryl Sulfate

25(b) Insecticide Soybean Oil

25(b) Fungicide Thyme

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EPA Status Pesticide Type Comments Active Ingredients

25(b) Fungicide, Insecticide, Miticide Thyme Oil

25(b) Insecticide White Pepper

Sec 3 Products Insecticide Azadirachtin

Sec 3 Products Fungicide Bacillus

Amyloliquefaciens

Strain D747

Sec 3 Products Fungicide For use in protected

growing environments

only (for example,

greenhouses)

Bacillus Pumilus Strain

GHA 180

Sec 3 Products Fungicide Bacillus Subtilis QST713

Strain

Sec 3 Products Insecticide Bacillus Thuringiensis

SSP. Aizawai

Sec 3 Products Insecticide Canola Oil

Sec 3 Products Insect Repellent Capsicum Oleoresin

Extract

Sec 3 Products Insecticide Ground application only

to nonblooming plants.

Chromobacterium Sub

Strain PRAA4-1 Cells

Sec 3 Products Fungicide, Insecticide Clarified Hydrophobic

Extract of Neem Oil

Sec 3 Products Fungicide Copper Octanoate

Sec 3 Products PGR Cytokinin (Kinetin)

Sec 3 Products Insecticide Diatomaceous Earth

Sec 3 Products PGR Gibberellins (Gibberellic

Acid)

Sec 3 Products PGR Harpin Alpha Beta

Sec 3 Products Antimicrobial, Fungicide No foliar applications

allowed.

Hydrogen Peroxide

Sec 3 Products PGR Applications allowed in

furrow at planting or in

hydroponics only.

IBA (Indole-3Butyric

Acid)

EPA Status Pesticide Type Comments Active Ingredient

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Sec 3 Products Insecticide, PGR Kaolin

Sec 3 Products Insecticide Mineral Oil

Sec 3 Products Fungicide Use only allowed prior

to final transplant,

unless grown in

recirculating

hydroponics systems.

Mono-Potassium and

Di-Potassium Salts of

Phosphorous Acid

Sec 3 Products Insecticide Monopotassium

Phosphate

Sec 3 Products Nematicide Myrothecium

Verrucaria

Sec 3 Products Fungicide, Insecticide Neem Oil, Cold Pressed

Sec 3 Products Insecticide Use allowed prior to

final transplant

Potassium Laurate

Sec 3 Products Fungicide, Insecticide Potassium Salts of Fatty

Acids

Sec 3 Products Insecticide Pyrethrins

Sec 3 Products Molluscicide Sodium Ferric EDTA

Sec 3 Products Fungicide Trichoderma

Asperellum Strain